The Independent Data and Safety Monitoring Board (DSMB) has completed its fourth planned review of the data from a Phase 3 clinical trial, BETonMACE, assessing the cardiovascular risk reduction effects of Resverlogix's (OTCPK:RVXCF) lead product candidate apabetalone (RVX-208) in high-risk type 2 diabetic patients. No safety signals or efficacy concerns were identified.
The DSMB recommends that the study continue as planned. According to ClinicalTrials.gov, the primary completion date is September 2018.
BETonMACE has ~1,600 patients enrolled so far with some being on treatment for over 76 weeks.
Apabetalone works via an epigenetic mechanism called BET (bromodomain and extra-terminal) inhibition which regulates disease-causing genes. It specifically inhibits the second bromodomain (BD2) within the BET protein called BRD4, thereby producing a potential treatment benefit in patients with CV disease, diabetes, chronic kidney disease, Alzheimer's and other conditions.
Previously: Late-stage study underway for Resverlogix's lead product candidate for CV disease (Nov. 11, 2015)